{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T16:52:08Z","timestamp":1792687928675,"version":"4.5.0"},"reference-count":44,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T00:00:00Z","timestamp":1770076800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100014188","name":"Ministry of Science and ICT","doi-asserted-by":"crossref","award":["2710000032"],"award-info":[{"award-number":["2710000032"]}],"id":[{"id":"10.13039\/501100014188","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100014188","name":"Ministry of Science and ICT","doi-asserted-by":"crossref","award":["RS-2022-00140577"],"award-info":[{"award-number":["RS-2022-00140577"]}],"id":[{"id":"10.13039\/501100014188","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Delayed or non-union fractures comprise 5\u201310% of cases, indicating the need for biologic interventions. Recombinant human bone morphogenetic protein-2 (rhBMP-2) is a potent osteoinductive agent; yet, collagen carrier-based uncontrolled release causes adverse events. We evaluated the safety and efficacy of a hydroxyapatite (HA) carrier-based rhBMP-2 delivery system for acute traumatic upper and lower fractures exhibiting bone defects. Methods: This prospective, multicenter, single-arm clinical trial enrolled 90 patients who underwent surgery using a hydroxyapatite (HA) carrier-based rhBMP-2 delivery system (NovosisTM). Radiographically validated union at 6 and 12 months post-surgery and treatment success (union without additional surgery) were used to assess efficacy. The incidence, type, and severity of all device-related adverse events during follow-up were monitored by investigators to evaluate safety. Results: Of the 90 patients enrolled, 81 were included in the full analysis set. The mean age was 58.5 years, and 18.6% (15\/81) had open fractures. At 6 months post-surgery, radiographically validated union was achieved in 81.5% (66\/81) of patients, increasing to 96.2% (77\/81) at 12 months after surgery. Treatment success was 95.0% (76\/81). Adverse events were rare (1\/81, 1.2%). No ectopic ossification, systemic complications, or severe inflammatory responses were observed. Conclusions: HA-based rhBMP-2 intervention demonstrated favorable union rates and safety with minimal complications in acute upper and lower fractures with bone defects. The biocompatibility and controlled-release properties of HA likely improved efficacy and reduced complications. Results should be interpreted as feasibility data from a heterogeneous case series without a control group. Larger randomized controlled comparative trials are warranted for optimal dosing and evaluating efficacy and cost-effectiveness.<\/jats:p>","DOI":"10.3390\/jcm15031176","type":"journal-article","created":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T09:00:58Z","timestamp":1770109258000},"page":"1176","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Safety and Efficacy of rhBMP-2 for Treating Acute Traumatic Fractures of the Upper and Lower Extremities: A Multicenter Prospective Study"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5373-169X","authenticated-orcid":false,"given":"Seungyeob","family":"Sakong","sequence":"first","affiliation":[{"name":"Department of Orthopaedic Surgery, Ajou University Hospital, School of Medicine, Ajou University, Suwon 16499, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seokjun","family":"Hong","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Ajou University Hospital, School of Medicine, Ajou University, Suwon 16499, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7566-6945","authenticated-orcid":false,"given":"Wonseok","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Korea University Guro Hospital, College of Medicine, Korea University, Seoul 03080, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6252-5310","authenticated-orcid":false,"given":"Seonghyun","family":"Kang","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Korea University Guro Hospital, College of Medicine, Korea University, Seoul 03080, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4962-3535","authenticated-orcid":false,"given":"Jae-Woo","family":"Cho","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Korea University Guro Hospital, College of Medicine, Korea University, Seoul 03080, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Whee Sung","family":"Son","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Yeungnam University Medical Center, College of Medicine, Yeungnam University, Daegu 42415, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeong-Seok","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Armed Forces Capital Hospital, Seongnam 13574, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3580-4175","authenticated-orcid":false,"given":"Chang-Jin","family":"Yon","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Keimyung University Dongsan Hospital, School of Medicine, Keimyung University, Daegu 42601, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9764-3912","authenticated-orcid":false,"given":"Won-Tae","family":"Cho","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Ajou University Hospital, School of Medicine, Ajou University, Suwon 16499, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jong-Keon","family":"Oh","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Korea University Guro Hospital, College of Medicine, Korea University, Seoul 03080, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,2,3]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"e162775","DOI":"10.1001\/jamasurg.2016.2775","article-title":"Epidemiology of fracture nonunion in 18 human bones","volume":"151","author":"Zura","year":"2016","journal-title":"JAMA Surg."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"264","DOI":"10.1530\/EOR-23-0047","article-title":"Biological aspects to enhance fracture healing","volume":"8","author":"Rodham","year":"2023","journal-title":"EFORT Open Rev."},{"key":"ref_3","first-page":"143","article-title":"Management of segmental bone defects","volume":"23","author":"Mauffrey","year":"2015","journal-title":"J. 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